MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd facs¿ lyse wash assistant was found leaking uncontained biohazard during use.The following has been provided by the initial reporter: was the leak fluid or air? (if air, no further questions required).- liquid.Was the leak contained within the instrument? - not contained.Was there spray of liquid? - no.What was the fluid that leaked? - biohazard.Did biohazard leak before or after waste line? after waste line was the waste mixed with decontamination/bleach? - no.Was the customer/bd personnel physically in contact with the fluid? - no.On (b)(6) 2021 10:10:38 (gmt) customer has reported that the waste tank is leaking.They have inspected the probe and connectors and confirm the leakage is from the tank itself.

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is only limited to bd facs lyse wash assistant, part # 337146 and serial # (b)(6).Problem statement: customer reported a complaint regarding an instrument's waste tank leaking.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 20sep2020 to 20sep2021.Complaint trend: there are 4 complaints related to the issue of the instrument's waste tank leaking; date range from 20sep2020 to 20sep2021.Manufacturing device history record (dhr) review: dhr part # 337146 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the waste leakage not contained within the instrument was due to a worn waste tank.The customer had initially reported the waste leakage and reported that they had inspected the probes and waste connectors to confirm the leakage to be from the waste tank.The tsr (technical service representative) assisting the customer sent the customer a new waste tank, and the customer was able to install the tank with no issues.No parts were requested for evaluation as the waste tank is not a returnable part and was discarded.After the repair the customer confirmed that the instrument was tested and performing as expected.Although the leakage of biohazard has the potential for injury and contamination, no customer or bd personnel came in direct contact and was thus not harmed due to the issue.The leakage was not under pressure and did not significantly increase the risk of exposure.The customer confirmed that though patient samples were used, they were not used in any treatment due to the leakage and didn¿t harm the patient in any way.The safety risk is severe, s4, though there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4) install date: (b)(6) 2012 defective part number: 33634907 - assembly waste bottle services work order notes: subject / reported: 337146 - bd facs lyse wash assistant - waste tank leaking problem description: customer has reported that the waste tank is leaking.They have inspected the probe and connectors and confirm the leakage is from the tank itself.Work performed: customer called to say that she has received the new waste tank and it has resolved the issue cause: waste tank issue solution: the instrument is working well returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.Risk analysis: risk management file part # (b)(4), rev.03/vers.C, lyse wash assistant fmea disinfectant project was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes/no id: 20.1 item: bd disinfectant function: contain the waste potential failure mode: integrity of waste tank compromised potential causes: incompatibility of antifoam with pp waste tank material local and next-level effects: waste leaks out of the tank.Hazards: chemical/biohazard due to incompatible material/chemical reaction risk controls: disinfectant added to waste tank; samples lysed and/or fixed; anti-foam msds effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.Probability: 1 severity: 4 risk index: 4 output: none.Mitigation(s) sufficient yes/no root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn waste tank.Conclusion: based on the investigation results, the root cause of the leakage of waste not contained within the instrument was due to a worn waste tank.The customer reported the leakage and was able to confirm that the issue was with the waste tank itself rather than the probes or connectors.The tsr sent the customer a new waste tank and the customer was able to install it themselves.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk is severe, s4, though there was no impact to customer health or safety.

Event Description

It has been reported that one bd facs¿ lyse wash assistant was found leaking uncontained biohazard during use.The following has been provided by the initial reporter: 1.Was the leak fluid or air? (if air, no further questions required).- liquid 2.Was the leak contained within the instrument? - not contained 3.Was there spray of liquid? - no 4.What was the fluid that leaked? - biohazard 5.Did biohazard leak before or after waste line? after waste line 6.Was the waste mixed with decontamination/bleach? - no 7.Was the customer/bd personnel physically in contact with the fluid? - no on (b)(6) 202110:10:38 (gmt), customer has reported that the waste tank is leaking.They have inspected the probe and connectors and confirm the leakage is from the tank itself.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12628545
• MDR Text Key: 283253710
• Report Number: 2916837-2021-00395
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1